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Local Doctor Raised Concerns About Avandia

Wednesday, June 06, 2007

A controversial diabetes drug was on trial in Washington, but two of the major players -- a company and a doctor -- are based in the Triangle.

The diabetes drug Avandia has come under fire after a newspaper article last month claimed the drug increased the risk of heart attacks.

A UNC doctor raised the same concerns about Avandia eight years ago then received a call from a Glaxo employee.

The controversial drug has far-reaching, national ramifications.

"This is an extremely important issue," said Dr. Steven Nissen, heart specialist. "It affects all 300 million Americans."

Wednesday's congressional hearing in Washington was streamed live on government Web sites. The debate over whether RTP-based GlaxoSmithKline tried to silence a Chapel Hill Doctor years ago took center stage.

"It is really an honor to be called to testify before this committee," said Dr. John Buse, UNC School of Medicine.

He testified Wednesday that he first raised concerns about Advandia in the year 2000, saying the drug could increase a patient's risk of heart attacks.

Dr. Buse said after that, he received a call from a Glaxo employee suggesting the company was very upset Buse went public and that his statements were hurting Glaxo's bottom line.

"There was a notion that the market capitalization of the company had decreased by approximately $4 billion," said Dr. Buse. "There were people in the company who felt that I might be liable for that."

Dr. Buse later clarified his statements, but he did not say whether he was pressured to be quiet.

"GlaxoSmithKline does not condone any kind of effort to suppress open scientific dialogue," said Chris Viehbacher, GSK executive. "It's out culture to do the reverse."

Glaxo stands behind its drug and said it did not silence Dr. Buse years ago.

"If Dr. Buse felt there was some element here that was not appropriate to that discussion of scientific evidence, we regret that," said Viehbacher.

Wednesday's the FDA called for new warning on Avandia and another diabetes drug manufactured by another company.

The warnings would be the most serious safety warning that can be put on drug labels.

In addition to Glaxo's verbal endorsement of the drug, it has taken out full-page ads in newspapers showing its support of Advandia.

(Copyright ©2009 WTVD-TV/DT. All Rights Reserved.)

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